Oseltamivir

What it is and how it works

Mechanism of Action Oseltamivir is an antiviral drug with activity against influenza virus .

Indications

Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use : Not a substitute for annual influenza vaccination. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. Not recommended for patients with end-stage renal disease not undergoing dialysis. Treatment of Influenza Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Prophylaxis of Influenza Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

Dosage and administration (summary)

Treatment of influenza Adults and adolescents (13 years and older): 75 mg twice daily for 5 days Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days Renally impaired adult patients (creatinine clearance >30 to 60 mL/min): Reduce to 30 mg twice daily for 5 days Renally impaired adult patients (creatinine clearance >10 to 30 mL/min): Reduce to 30 mg once daily for 5 days ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle.

Contraindications

Oseltamivir phosphate for oral suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme . Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate for oral suspension

Warnings and precautions

Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior.

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies with oseltamivir phosphate for oral suspension in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Storage and supply

Storage Store dry powder at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) . Preserved in well closed container. Store constituted oral suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze.

Source: Oseltamivir Phosphate (Oseltamivir Phosphate) — US FDA prescribing information, 2024-05-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.